Zimmer Biomet, Inc.: VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Recall number

Z-1029-2018

Recalling firm

Zimmer Biomet, Inc.

Product

VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Status

Terminated

Initiated

2017-11-29

Posted

not on file

Terminated

2020-04-02

Reason

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Root cause

Packaging

Action

A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi

Quantity

13,227 in total

Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Lot, serial or model codes

Item Number: 00-7843-012-08 Lot Numbers: 62053685 62116471 Item Number: 00-7843-013-08 Lot Number: 62184774 Item Number: 00-7843-014-08 Lot Numbers: 62184777 62158847 62184778 Item Number: 00-7843-013-81 Lot Numbers: 61987954 61815082 62116484 61956726 Item Number: 00-7843-015-08 Lot Number: 62158851 Item Number: 00-7843-013-82 Lot Numbers: 61937673 61759258 61951276 61815083 62120674 61829373 77000819 Item Number: 00-7843-015-81 Lot Numbers: 61968101 61781981 61968103 Item Number: 00-7843-015-82 Lot Numbers: 61834826 61932605 Item Number: 00-7843-016-81 Lot Numbers: 61735809 61759260 Item Number: 00-7843-016-82 Lot Numbers: 62029071 61775246 62029071N 61981820 77000820

510(k) numbers

["K030079"]

PMA numbers

not on file

Product code

LPH

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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