Exact FDA event identifier

Event 78762

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 01, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) 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.

Z-0721-2018

Recall number: Z-0721-2018
Initiated: August 01, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 3,350 units total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

compromised sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026); c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026); d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)

Distribution pattern

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.

device · product 2 of 2

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.

Z-0722-2018

Recall number: Z-0722-2018
Initiated: August 01, 2017
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 38,069 units total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

compromised sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)