Recalls / —
—#173538
Product
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- FDA product code
- FSM — Tray, Surgical, Instrument
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lots: 251059 254986 203752 260646 263012 264753 2111048 2111052 2111050 2111051 21110107 21110106 21110117 2291017 2881019 3231032 2981046 3341019 831129 1961120 21110105 21110108 1961120 1961120 1961120 3461146 1961120 1961120 1961120 1961120 1961120 3461146 1081211 1081211 1081211 1951228 1951228 1951228 1951228 1951228 3181203 3181203 3181203 3181203 1411303 1411303¿ 1411303 1721312 1721312 1721312 2631353 2631353 3461146 MB33730 171421 1721312 ME50120 ME50130 1641404 MH50820 1641404 1641404 2331407 1721312 1961120 2291016 3461146 2331407 2331407 ML35700 2331407 2631048 ML56520 2331407 2331407 2331407 2331407 961509 961509 961509 961509 MO93600 MO93610 961509 961509 1631512 1631512 2261523 2261523 2261523 2681520 2681520 2681520 443894 2681520 443894 443894 476977 476977 501920 501920 530934 538816
Why it was recalled
Lack of an adequate sterilization validation.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Medical Device Recall notification letters dated 6/10/19 were sent to customers.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
Timeline
- Recall initiated
- 2019-06-10
- Terminated
- 2020-09-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.