Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
FDA Recall Z-1087-2019 · Posted None
Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-03-01
Date Terminated2020-05-27
Product Quantity809 units total
Reason for Recall
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Firm Action
Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees.
All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x.
Accounts asked to review 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.
Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.