Zimmer, Inc.: 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT

Recall number

Z-1041-2014

Recalling firm

Zimmer, Inc.

Product

2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT

Status

Terminated

Initiated

2013-10-11

Posted

2014-02-20

Terminated

2017-04-14

Reason

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.

Root cause

Packaging

Action

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.

Quantity

7,044,680 total

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.

Lot, serial or model codes

61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816

510(k) numbers

["K082527","K083654"]

PMA numbers

not on file

Product code

HWC

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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