Zimmer Biomet, Inc. Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 00401000042 00401000043 00401000044 00401000045 00401000046 00401000047 00401000048 00401000049 00401000050 00401000051 00401000052 00401000053 00401000054 00401000055 00402100857 00402100863 00402101243 004021012 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 00401000042 00401000043 00401000044 00401000045 00401000046 00401000047 00401000048 00401000049 00401000050 00401000051 00401000052 00401000053 00401000054 00401000055 00402100857 00402100863 00402101243 004021012
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
All product manufactured prior to January 2014.
Products Sold
All product manufactured prior to January 2014.
Zimmer Biomet, Inc. is recalling Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 due to Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Recommended Action
Per FDA guidance
The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, 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 CorporateQuality.PostMarket@zimmerbiomet.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026