Peri Scr. 3.5mm X 10mm recallZ-1040-2014 · Zimmer, Inc. · initiated Oct 11, 2013

Class II Terminated All recalls posted in February 2014

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 Zimmer, Inc. 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

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

FDA root cause category: Packaging

What the company is doing

Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Recall details

Recall number: Z-1040-2014
Recall class: Class II
Status: Terminated
Initiated by the company: Oct 11, 2013
Posted by the FDA: Feb 20, 2014
Recalling firm: Zimmer, Inc.
Quantity: 7,044,680 total
Product code: HWC
FDA submissions: K112885
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

Product description

PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT SCR X 20MM 3.5MM CORT SCR X 22MM 3.5MM CORT SCR X 24MM 3.5MM CORT SCR X 26MM 3.5MM CORT SCR X 28MM 3.5MM CORT SCR X 30MM 3.5MM CORT SCR X 32MM 3.5MM CORT SCR X 34MM 3.5MM CORT SCR X 36MM 3.5MM CORT SCR X 38MM 3.5MM CORT SCR X 40MM 3.5MM CORT SCR X 42MM 3.5MM CORT SCR X 44MM 3.5MM CORT SCR X 46MM 3.5MM CORT SCR X 48MM 3.5MM CORT SCR X 50MM 3.5MM CORT SCR X 52MM 3.5MM CORT SCR X 54MM 3.5MM CORT SCR X 56MM 3.5MM CORT SCR X 58MM 3.5MM CORT SCR X 60MM 3.5MM CORT SCR X 65MM 3.5MM CORT SCR X 70MM 3.5MM CORT SCR X 75MM 3.5MM CORT SCR X 80MM 3.5MM CORT SCR X 85MM 3.5MM CORT SCR X 90MM 3.5MM CORT SCR X 100MM 3.5MM CORT SCR X 105MM 3.5MM CORT SCR X 110MM CANC SCR 4.0MM X 10MM CANC SCR 4.0MM X 10MM FUL CANC SCR 4.0MM X 12MM CANC SCR 4.0MM X 12MM FUL CANC SCR 4.0MM X 14MM CANC SCR 4.0MM X 14MM FUL CANC SCR 4.0MM X 16MM CANC SCR 4.0MM X 16MM FUL CANC SCR 4.0MM X 18MM CANC SCR 4.0MM X 18MM FUL CANC SCR 4.0MM X 20MM CANC SCR 4.0MM X 20MM FUL CANC SCR 4.0MM X 22MM CANC SCR 4.0MM X 22MM FUL CANC SCR 4.0MM X 24MM CANC SCR 4.0MM X 24MM FUL CANC SCR 4.0MM X 26MM CANC SCR 4.0MM X 26MM FUL CANC SCR 4.0MM X 28MM CANC SCR 4.0MM X 28MM FUL CANC SCR 4.0MM X 30MM CANC SCR 4.0MM X 30MM FUL CANC SCR 4.0MM X 32MM CANC SCR 4.0MM X 32MM FUL CANC SCR 4.0MM X 34MM CANC SCR 4.0MM X 34MM FUL CANC SCR 4.0MM X 36MM CANC SCR 4.0MM X 36MM FUL CANC SCR 4.0MM X 38MM CANC SCR 4.0MM X 38MM FUL CANC SCR 4.0MM X 40MM CANC SCR 4.0MM X 40MM FUL

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

61337161 61251498 61251499 61220432 61553288 61966252 61966257 60856802 60871924 60871946 60837236 61168818 61168821 61251340 61168823 61251341 61168825 61216588 61247526 61168827 61216589 61247527 61168829 61216590 61247528 61168830 61216591 61247529 61168831 61247530 61168833 61216593 61247531 61168835 61247532 61168837 61216596 61247533 61168839 61168841 61168842 61168843 61168845 61247536 61168847 61223705 61168849 61168850 61168852 61168854 61168856 61168858 61168859 61168860 61168861 61168862 61567437 61411579 61678383 61678382 61835910 61835909 61214649 61216599 61214650 61216602 61251346 61216605 61591005 61190532 61190535 61740546 61190538 61190539 61401997 61190540 61190543 61560426 61823977 61190544 61190546 61740547 61190547 61190549 61740548 61190551 61190552 61560430 61190554 61190555 61560431 61190618 61190619 61740550 61190620 61190627 61560427 61190628 61190629 61401998 61190630 61190632 61740551 61190633 61190634 61740552 61190635 61190636 61740553 61190638 61190639 61190640 61190641 61190642 61740554 61190643

Other devices under the same FDA submission

3 devices cleared under K112885 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

NA 47-4840-014-00
Zimmer, Inc. · WASHER, BOLT NUT
1 report
NA 47-4840-035-01
Zimmer, Inc. · WASHER, BOLT NUT
1 report
NA 47-4840-040-01
Zimmer, Inc. · WASHER, BOLT NUT
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 66500).

Z-1019-2014 · Terminated
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several …
Z-1021-2014 · Terminated
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Z-1023-2014 · Terminated
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
Z-1024-2014 · Terminated
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM …
Z-1025-2014 · Terminated
HGP II ACETABULAR CUP BON
Z-1026-2014 · Terminated
HGP II ACETABULAR CUP MOD
Z-1029-2014 · Terminated
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX S…
Z-1031-2014 · Terminated
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Z-1032-2014 · Terminated
CPT 12/14 COCR (various sizes)
Z-1033-2014 · Terminated
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
Z-1034-2014 · Terminated
6 DEGREE COCR FEM HEAD 36
Z-1036-2014 · Terminated
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Z-1042-2014 · Terminated
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUC…

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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