Zimmer Biomet, Inc. Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 001181 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 001181
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
All products manufactured prior to January 2014.
Products Sold
All products manufactured prior to January 2014.
Zimmer Biomet, Inc. is recalling Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 001181005 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