FDA Device recall Z-0722-2018

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis

FDA Device
Class II
terminated
Published 2018-03-07

On 2018-03-07 the FDA classified a Class II recall of Versys 6 inch Beaded Full Coat Plus Hip Prosthesis by Zimmer Biomet, citing the products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0722-2018
Classification	Class II
Status	terminated
Initiated	2017-08-01
Published	2018-03-07
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Biomet
Distribution	US

Product

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

Reason

The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

Identifiers

code_info	a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before… a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025); c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026); d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026); e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026); f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025); g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026); h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026); i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026); j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026); k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026); l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026); m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026); n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025); o. Item No. 00784302006 (Lot Expiration Date Befor

code_info

a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before…

a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025); c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026); d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026); e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026); f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025); g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026); h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026); i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026); j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026); k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026); l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026); m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026); n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025); o. Item No. 00784302006 (Lot Expiration Date Befor

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.