Zimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors
Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue is a packaging defect (missing tip protectors) rather than a direct contamination or structural failure, fitting the Moderate severity criteria for minor labeling or packaging errors.
Plain-English summary
Zimmer Biomet, Inc. is recalling 885 units of the Ziptight Ankle Syndesmosis Fixation Device, a titanium implant used for surgical repairs of soft tissue. The recall was initiated because the devices were packaged without the required tip protectors.
The affected devices were distributed domestically to 29 states and internationally to Argentina, Australia, Canada, Costa Rica, Japan, and the Netherlands. Specific lot numbers and expiration dates are listed in the agency's structured product information.
Healthcare providers and patients should check their inventory or medical records for the specific item and lot numbers listed in the recall notice. If the device is found, it should be removed from use and returned to the manufacturer or the FDA as directed.
The recalled product
- Product
- Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 885
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Item No. 905759
- Lot No. (UDI No.): 58860 ((01)00880304476103(17)220523(10)058860)
- 58880 ((01)00880304476103(17)220608(10)058880)
- 58890 ((01)00880304476103(17)220608(10)058890)
- 58910 ((01)00880304476103(17)220608(10)058910)
- 116030 ((01)00880304476103(17)220519(10)116030)
- 169780 ((01)00880304476103(17)220609(10)169780)
- 169790 ((01)00880304476103(17)220608(10)169790)
- 213450 ((01)00880304476103(17)220609(10)213450)
- 213480 ((01)00880304476103(17)220607(10)213480)
- 374420 ((01)00880304476103(17)220319(10)374420)
- 392530 ((01)00880304476103(17)220610(10)392530)
- 476670 ((01)00880304476103(17)220607(10)476670)
- 503830 ((01)00880304476103(17)220608(10)503830)
- 614910 ((01)00880304476103(17)220421(10)614910)
- 670640((01)00880304476103(17)220621(10)670640)
- 728190 ((01)00880304476103(17)220606(10)728190)
- 984070 ((01)00880304476103(17)220512(10)984070)
- 984080 ((01)00880304476103(17)220607(10)984080)
Distribution
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