Stryker Orthopaedics Cancellous Bone Screw recallZ-2121-2009 · Stryker Howmedica Osteonics Corp. · initiated Jun 26, 2009

Terminated All recalls posted in September 2009

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Recall details

Recall number: Z-2121-2009
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Jun 26, 2009
Posted by the FDA: Sep 14, 2009
Recalling firm: Stryker Howmedica Osteonics Corp.
Quantity: 51,113 total - all sizes.
Product code: HWC
FDA submissions: K873251
Distribution: Worldwide Distribution

Product description

Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 40 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixtures that may be used during knee and hip replacement procedures.

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

Lot number: 2030-6540-1; 6.5 CANCELLOUS BONE SCREW 40mm EELMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm EEJMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm EEKMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKPMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKTMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm LN6MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKRMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NNLMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NMYMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NNWMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm WH1MKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm WH2MKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 163MLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15WMLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 161MLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15RMLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 162MLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15YMLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX2MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX4MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX3MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX1MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JKTMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JKWMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JN3MLE 22-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MR0MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MPXMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MPYMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm HW0MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HVXMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW6MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW4MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW2MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm 12WMNE 07-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3J3MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3A9MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3A8MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 788MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 789MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T6MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T4MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T7MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T5MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8J8MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8JDMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8NTMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8J9MNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8NPMNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8JAMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm MER824 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91D 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER825 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91A 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91E 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXX 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXW 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXT 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXV 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDY0 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERJA8 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MET042 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31L 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31N 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31M 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31P 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31R 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET03Y 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET040 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET041 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET7DT 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET8YM 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METAM8 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET7DR 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METM1H 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM4 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM6 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET8YN 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METAMA 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM5 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm METMR6 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm METMR7 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MET7DV 06-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1L6 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1A0 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1L4 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1A1 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA634 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA691 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA60V 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA6LX 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA712 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1WM 25-Jan-2014

Other devices under the same FDA submission

7 devices cleared under K873251 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Torx 2030-6525-1
Howmedica Osteonics Corp. · Screw, fixation, bone
27 reports
Torx 2030-6530-1
Howmedica Osteonics Corp. · Screw, fixation, bone
18 reports
Torx 2030-6535-1
Howmedica Osteonics Corp. · Screw, fixation, bone
13 reports
Torx 2030-6520-1
Howmedica Osteonics Corp. · Screw, fixation, bone
9 reports
Torx 2030-6540-1
Howmedica Osteonics Corp. · Screw, fixation, bone
9 reports
Torx 2030-6516-1
Howmedica Osteonics Corp. · Screw, fixation, bone
7 reports
Torx 2030-6545-1
Howmedica Osteonics Corp. · Screw, fixation, bone
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 52713).

Z-2117-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 16 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2118-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 20 mm; Sterile Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are opt…
Z-2119-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile; Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2120-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile; Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2122-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 45 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2123-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2124-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 60 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2125-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 15 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2126-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 20 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2127-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2128-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 30 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2129-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 35 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2130-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 40 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2131-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…
Z-2132-2009 · Terminated
Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixt…
Z-2133-2009 · Terminated
Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixt…
Z-2134-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 15 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430.
Z-2135-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2136-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 25 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2137-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 30 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2138-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2139-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2140-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 45 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2141-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2142-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 55 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2143-2009 · Terminated
Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 60 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Z-2176-2009 · Terminated
Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 35 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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