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Terminated

(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290

FDA Recall Z-0097-2021 · Posted 2020-10-09

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2020-09-03
Date Terminated2022-12-20
Product Quantity48 devices

Reason for Recall

Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

Firm Action

All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for. An inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as "not in inventory and unavailable for return." Zimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. Product returned from the field will be scrapped.

Root Cause

Process control

Distribution Pattern

Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051569RINGLOC BI-POLAR ACETABULAR COMPONENTBiomet, Inc. · 2005-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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