Zimmer Biomet, Inc. Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 0
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 Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 0058 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