CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Versys Beaded Full Coat Plus Hip Prosthesis recalled by Zimmer Biomet
Zimmer Biomet is recalling Versys Beaded Full Coat Plus Hip Prosthesis, distributed nationwide in the US. The recall was initiated on 1 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0722-2018
- FDA event ID
- 78762
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2017
- FDA classified
- 26 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 1 Aug 2017 | Recall initiated by company | |
| 26 Feb 2018 | Classified by FDA | +209 days |
| 7 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Versys Beaded Full Coat Plus Hip Prosthesis recalled?
Yes. Zimmer Biomet recalled Versys Beaded Full Coat Plus Hip Prosthesis on 1 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0722-2018.
Why was it recalled?
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Which lots are affected?
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 Before 11/30/2025); p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026); q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026); r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025); s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026); t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025): u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026); v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026); w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026); x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026); y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025); z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026); aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026); ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026); ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026); ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026); ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)
Where was it sold?
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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