BIO-MODULAR SHOULDER SYSTEM recallZ-0533-2020 · Zimmer Biomet, Inc. · initiated Aug 21, 2019

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

FDA root cause category: Environmental control

What the company is doing

On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.

Recall details

Recall number

Z-0533-2020

Status

Terminated

Initiated by the company

Aug 21, 2019

Recalling firm

Zimmer Biomet, Inc.

Quantity

214741

Product code

MBF

FDA submissions

K043100

Distribution

US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

Product description

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• BIO-MODULAR SHOULDER SYSTEM 113867

  Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
  1 recall0 reports
• BIO-MODULAR SHOULDER SYSTEM 113865

  Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
  1 recall0 reports
• BIO-MODULAR SHOULDER SYSTEM 113863

  Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
  1 recall0 reports

Product lines

• BIO-MODULAR SHOULDER SYSTEMBiomet Orthopedics, LLC · 9 models · 6 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 83783).

• Z-0519-2020 · Terminated
  Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 17837…
• Z-0520-2020 · Terminated
  COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM5…
• Z-0523-2020 · Terminated
  Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-10320…
• Z-0526-2020 · Terminated
  Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 C…
• Z-0527-2020 · Terminated
  Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-…
• Z-0528-2020 · Terminated
  HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA…
• Z-0529-2020 · Terminated
  GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical de…
• Z-0530-2020 · Terminated
  BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical dev…
• Z-0531-2020 · Terminated
  2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.